As is well known, surgical instruments used in the healthcare industry must be sterilized before and/or after each use. Sterilization, of course, frees instruments from microorganism contamination, to prevent infections and the spread of diseases among patients. All medical procedures rely upon a stringent program of sterilization.
The medical device industry has addressed the sterilization requirements in the surgical field by offering two general types of surgical instruments: reusable instruments and single use, or disposable, instruments. Reusable instruments are typically composed of stainless steel and are typically sterilized before their initial use and then cleaned and resterilized prior to each subsequent use thereof. Single use or disposable instruments, on the other hand, are often fabricated primarily from plastic materials, thereby reducing costs associated with manufacture, and are discarded after use in a single procedure.
With respect to reusable surgical instruments, e.g., forceps, graspers, dissectors, probes, hemostats, scissors and the like, sterilization and resterilization have historically been accomplished using various sterilization modalities. In a broad sense, these sterilization processes generally involve placing instruments to be sterilized in a tray, wrapping and sealing the instruments and the tray with a semi-permeable wrapping material (also called “sterilization wrap” or “sterile wrap”) to form a sterilization pack or wrapped set. Next, the sterilization pack is placed in a sterilization chamber where the instruments are exposed to a sterilization medium of either steam or ethylene oxide, for sterilization. Of these two primary historical sterilization media, steam sterilization has traditionally been the overwhelmingly dominant method of sterilization in the surgical instrument field. After sterilization, the sterilization pack is cooled, dried and placed on a storage shelf or cart until the surgical instruments are needed for a surgical procedure.
One long and continuing problem encountered with sterilization packs is tears and rips of sterilization wrap prior to use of the sterilized instruments. The tears and rips may occur on both the inner and outer surfaces of the sterilization pack. The inner surface of the wrap refers to the wrap surface that is in contact with a tray. Most inner surface rips are caused by the corners and edges of the tray. This is because during repeated use, the trays may begin to oxidize and degrade, exposing sharp or rough corners and edges. The outer surface of the wrap refers to the exterior surface of a sterilization pack. The outer surface rips typically occur during shelving when a fully loaded tray, weighing up to 30 pounds each, is dragged and slid for relocation. Such dragging and sliding not only leave abrasion marks but also cause rip damages on the outer surface of the wrap by any sharp object that the pack may come in contact with. Of course, once a sterilization wrap is torn or ripped, the entire contents are deemed contaminated with bacteria and the like and, therefore, must be re-wrapped and then re-sterilized.
The problem is exacerbated by the fact that many sterilization packs become “wet packs,” i.e. wrapped trays containing surgical instruments having surface moisture on the inside and/or outside of the wrapped trays during and after steam and ethylene oxide sterilization. The residual moisture makes the sterilization wrap more prone to rips and tears during sterilization processes.
One common solution to the problem focuses on rips and tears of the inner surface of the wrap caused by the tray. For example, Xodus Medical Inc. sells surgical tray corner protectors made out of regular or reticulated plastic at the dimension of 6″×6″×1⅝″ for placing to the corners of a surgical tray. U.S. Pat. No. 7,780,136 discloses a surgical tray corner protector with improved drainage and air flow which comprises a support base, a side wall extending along an edge of the support base, and a plurality of apertures extending through the support base. U.S. Pat. Appl. Pub. No. 2008/0253947 discloses a foam plastic corner protector which is designed to be engaged with a surgical tray corner. While the corner protectors may guard against tears caused by the tray, they fail to prevent tears and rips on the outer surface of the wrap.
Another common practice is to provide additional layer of wrapping to reinforce the sterilization pack. This can be done by wrapping the sterilization tray with two sheets of wraps or two-ply wraps (also known as “double wrapping”), as disclosed in U.S. Pat. Nos. 5,635,134, 5,688,476, 6,406,764 and 6,517,916. However, the double wrapping practice is generally labor intensive and costly due to the increased consumption of the wrap material. Moreover, the double wrapping practice does not resolve the damages to the inner surface of the wrap.
What is desired, therefore, is a wrapping protector for sterilization trays which can be used to prevent tears and rips on the outer surface of the wrap. Preferably the wrapping protector can also be used directly on the tray so as to prevent tears and rips on the inner surface of the wrap. More preferably, the wrapping protector can be easily applied to a sterilization tray or a sterilization pack and also cost effective.